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Dazodalibep Dose 1 for Sjögren's Syndrome

Q: What are the safety considerations associated with administering Dazodalibep Dose 1 to patients?

Based on the phase of this trial and the available safety data, our team at Power rates Dazodalibep Dose 1 with a score of 3 in terms of safety.

Q: Are participants currently being enrolled in this study?

Indeed, data from clinicaltrials.gov shows that this investigation is actively enrolling participants. The trial was initially listed on March 11th, 2024 and last modified on April 2nd, 2024. Approximately 435 individuals are sought across four designated locations.

Q: Are there multiple testing facilities conducting this trial in Canada?

Four clinical trial sites are currently enrolling participants, such as Shores Rheumatology in Saint Clair Shores and <a href="https://www.withpower.com/clinical-trials/arthritis">Arthritis</a>, Rheumatic &#x26; Bone Disease Associates - P in Voorhees. Additionally, the Amarillo Center For Clinical Research - ClinEdge - PPDS is actively recruiting patients in Amarillo. There are also four more locations where patients can enroll for this study.

Q: How many individuals are partaking in this clinical trial as participants overall?

The study demands a cohort of 435 individuals meeting the defined eligibility criteria. Horizon Pharma Ireland, Ltd., headquartered in Dublin, Ireland, will oversee operations at various sites such as Shores Rheumatology in Saint Clair Shores, <a href="https://www.withpower.com/clinical-trials/michigan">Michigan</a> and <a href="https://www.withpower.com/clinical-trials/arthritis">Arthritis</a>, Rheumatic &#x26; Bone Disease Associates - P in Voorhees, <a href="https://www.withpower.com/clinical-trials/new-jersey">New jersey</a>.

Phase 3

Recruiting

Research Sponsored by Horizon Pharma Ireland, Ltd., Dublin Ireland

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 12, week 24

Awards & highlights

Study Summary

This trial aims to study the impact of dazodalibep on symptoms reported by patients with Sjogren's Syndrome. Additionally, it will assess the effects of dazodalibep on

Who is the study for?

This trial is for people with Sjögren's Syndrome who have moderate-to-severe symptoms. Participants must meet the 2016 ACR/EULAR criteria, have certain levels of symptom severity scores (ESSPRI ≥ 5 and ESSDAI < 5), test positive for specific autoantibodies, and still produce some saliva. They should be vaccinated against COVID-19 unless they opt out, not have a history of TB or recent exposure to it, and test negative for TB.Check my eligibility

What is being tested?

The study tests Dazodalibep's impact on patient-reported symptoms in those with Sjögren's Syndrome versus a placebo. It also looks at how well Dazodalibep improves systemic activity indicators, patient outcomes, and salivary flow. Safety and tolerability after multiple doses are evaluated as secondary objectives.See study design

What are the potential side effects?

While the side effects of Dazodalibep aren't detailed here, similar trials may involve risks like injection site reactions, flu-like symptoms, potential immune system changes leading to increased infection risk or allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 12, week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at week 12, week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 12, week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in Diary for Assessing Sjogren's Patient Reported Index (DASPRI ) score

Change from baseline in ESSPRI score

Secondary outcome measures

Change from baseline in 36-item Short Form Survey (SF-36) Physical Component Summary (PCS) score

Change from baseline in DASPRI Dryness

Change from baseline in DASPRI Fatigue

+13 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Dazodalibep Dose 2Experimental Treatment1 Intervention

Participants will be administered dose 2 of dazodalibep by IV infusion.

Group II: Dazodalibep Dose 1Experimental Treatment1 Intervention

Participants will be administered dose 1 of dazodalibep by intravenous (IV) infusion.

Group III: PlaceboPlacebo Group1 Intervention

Participants will be administered placebo by IV infusion.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Horizon Pharma Ireland, Ltd., Dublin IrelandLead Sponsor

30 Previous Clinical Trials

3,378 Total Patients Enrolled

AmgenLead Sponsor

1,374 Previous Clinical Trials

1,378,538 Total Patients Enrolled

1 Trials studying Sjögren's Syndrome

183 Patients Enrolled for Sjögren's Syndrome

MDStudy DirectorAmgen

919 Previous Clinical Trials

925,560 Total Patients Enrolled

1 Trials studying Sjögren's Syndrome

183 Patients Enrolled for Sjögren's Syndrome

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the safety considerations associated with administering Dazodalibep Dose 1 to patients?

"Based on the phase of this trial and the available safety data, our team at Power rates Dazodalibep Dose 1 with a score of 3 in terms of safety."

Answered by AI

Are participants currently being enrolled in this study?

"Indeed, data from clinicaltrials.gov shows that this investigation is actively enrolling participants. The trial was initially listed on March 11th, 2024 and last modified on April 2nd, 2024. Approximately 435 individuals are sought across four designated locations."

Answered by AI

Are there multiple testing facilities conducting this trial in Canada?

"Four clinical trial sites are currently enrolling participants, such as Shores Rheumatology in Saint Clair Shores and Arthritis, Rheumatic & Bone Disease Associates - P in Voorhees. Additionally, the Amarillo Center For Clinical Research - ClinEdge - PPDS is actively recruiting patients in Amarillo. There are also four more locations where patients can enroll for this study."

Answered by AI

How many individuals are partaking in this clinical trial as participants overall?

"The study demands a cohort of 435 individuals meeting the defined eligibility criteria. Horizon Pharma Ireland, Ltd., headquartered in Dublin, Ireland, will oversee operations at various sites such as Shores Rheumatology in Saint Clair Shores, Michigan and Arthritis, Rheumatic & Bone Disease Associates - P in Voorhees, New jersey."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Safety and Efficacy Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-Severe Symptom State

2024. "A Safety and Efficacy Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-Severe Symptom State". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06245408.

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